This letter concerns your firm's marketing of the product H S Joy of Love. A laboratory analysis conducted by the Food and Drug administration (FDA) concluded that your product contains piperadino vardenafil, an analog of vardenafil. Vardenafil is the active pharmaceutical ingredient in Levitra, an FDA-approved drug that is used to treat erectile dysfunction. Statements in the inserts that accompany HS Joy of Love describe its intended uses. These statements include, but are not limited to, the following:

H S Joy of Love -Chinese insert

• "It also can offer positive functions such as preventing blood vessel clotting and aging and completely improve weak body and sexual ability"

These statements make clear that H S Joy of Love is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body. Accordingly, H S Joy of Love is a drug, as defined by Section 201(g)(1) of the Federal Food, Drug and Cosmetic Act (Act), 21 U.S.C. § 321(g)(1).

Under Section 201(g)(1) of the Act (last sentence), the structure/function claims made for a dietary supplement must be made in accordance with Section 403(r)(6) of the Act, 21 U.S.C. §343(r)(6), or the product is subject to regulation as a drug. Section 403(r)(6) authorizes claims that describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body, or that characterize the way in which a nutrient or dietary ingredient maintains the structure or function of the body. In the case of H S Joy of Love, however, the sexual performance structure/function claims quoted above do not describe the effects of nutrients or dietary ingredients in the product. Rather, these claims are made for the product as a whole and relate to its piperadino vardenafil content. Since piperadino vardenafil is not a nutrient or dietary ingredient but a synthetic analog of vardenafil, claims about improvement of sexual function do not conform with Section 403(r)(6). Accordingly, H S Joy of Love is a drug within the meaning of Section 201(g)(1)(C).

Moreover, H S Joy of Love is a new drug, as defined by Section 201(p) of the Act, 21 U.S.C. § 321(p), because it is not generally recognized as safe and effective for its labeled uses.

Under Sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of H S Joy of Love without such an approved application violates these provisions of the Act.

Additionally, your product labeling does not declare that your product contains piperadino vardenafil. Further, the Chinese insert states "clinical experiments prove that Joy of Love is the only natural health product that can improve potency and energy instantly without causing any side effects." This statement falsely asserts that the product does not have the potential to cause side effects, even though piperadino vardenafil likely exhibits similar pharmacological action to vardenafil. This claim and the failure to disclose the presence of the piperadino vardenafil render your product's labeling false and misleading. H S Joy of Love is therefore misbranded under Section 502(a) of the Act, 21 U.S.C. § 352(a).

Furthermore, because H S Joy of Love is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use this product safely for its intended uses. Thus, H S Joy of Love's labeling fails to bear adequate directions for its intended uses, causing it to be misbranded under Section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1).

H S Joy of Love is also misbranded under Section 502(f)(2) of the Act, 21 U.S.C. § 352(f)(2), in that its labeling lacks adequate warnings for the protection of users. As noted, there is potential for adverse events associated with the use of H S Joy of Love, particularly since someone who takes H S Joy of Love would be unaware of the presence of an analog of vardenafil. For example, patients who take nitrates and consume H S Joy of Love are at risk of life-threatening hypotension.

The violations described above are not intended to be an all-inclusive list of your product's deficiencies. It is your responsibility to ensure that the drug products that you manufacture or distribute meet all of the requirements of the Act and its implementing regulations. Other federal agencies may take this Warning Letter into account when considering the award of contracts.

You must immediately correct these violations. If you do not immediately correct them, you may be subject to enforcement action against you without further notice. The Act provides for the seizure of illegal products and for an injunction against the manufacturers and distributors of illegal products. Individuals and businesses that violate the Act may also be subject to criminal prosecution.

You must notify this office in writing within 15 working days of receipt of this letter as to the steps that you have taken to correct the above-listed violations and to assure that similar violations will not recur. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be made. Furthermore, please advise this office what actions you will take to address product that you have already distributed. Additionally, if your firm does not manufacture the product identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the product is not the manufacturer, please include the name of your supplier in addition to the manufacturer. Address your reply to the U.S. Food and Drug Administration, 222 West 6th Street, Suite 700, San Pedro, CA 90731, Attention: Dr. James Lin, Compliance Officer.

A description of the new drug approval process can be found on FDA's internet website at http://www.fda.gov/cder/regulatory/applications/default.htm.Any questions regarding this process should be directed to the Food and Drug Administration, Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, Maryland 20857.